GLAXOSMITHKLINE Company Profile

What is the competitive landscape for GLAXOSMITHKLINE, and when can generic versions of GLAXOSMITHKLINE drugs launch?

GLAXOSMITHKLINE has one hundred and eighty-two approved drugs.

There are thirty-nine US patents protecting GLAXOSMITHKLINE drugs.

There are eight hundred and fifty-six patent family members on GLAXOSMITHKLINE drugs in fifty-five countries and one hundred and eighty-seven supplementary protection certificates in twenty countries.

Summary for GLAXOSMITHKLINE

International Patents:	856
US Patents:	39
Tradenames:	132
Ingredients:	105
NDAs:	182
Drug Master File Entries:	8
Patent Litigation for GLAXOSMITHKLINE:	See patent lawsuits for GLAXOSMITHKLINE
PTAB Cases with GLAXOSMITHKLINE as petitioner:	See PTAB cases with GLAXOSMITHKLINE as petitioner

Drugs and US Patents for GLAXOSMITHKLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	LAMICTAL XR	lamotrigine	TABLET, EXTENDED RELEASE;ORAL	022115-006	Jun 21, 2011	AB	RX	Yes	No	8,637,512		Y
Glaxosmithkline Llc	REQUIP	ropinirole hydrochloride	TABLET;ORAL	020658-004	Sep 19, 1997		DISCN	Yes	No
Glaxosmithkline	ZEJULA	niraparib tosylate	CAPSULE;ORAL	208447-001	Mar 27, 2017		RX	Yes	Yes	8,071,623		Y	Y

Expired US Patents for GLAXOSMITHKLINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	IMITREX	sumatriptan succinate	TABLET;ORAL	020132-001	Jun 1, 1995	6,020,001*PED
Glaxosmithkline	TAGAMET	cimetidine	TABLET;ORAL	017920-004	Dec 14, 1983	4,024,271
Glaxosmithkline	SEREVENT	salmeterol xinafoate	POWDER;INHALATION	020692-001	Sep 19, 1997	5,873,360*PED

Paragraph IV (Patent) Challenges for GLAXOSMITHKLINE drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Gum	2 mg		2013-01-22
	Extended-release Tablets	6 mg		2009-07-22
	Injection	6 mg/0.5 mL, 0.5 mL vials		2004-10-25
	Orally Disintegrating Tablets	25 mg, 50 mg, 100 mg, and 200 mg		2009-12-21
	Tablets	100 mg		2007-10-31
	Tablets	3 mg, 4 mg and 5 mg		2005-02-04
	Tablets	62.5 mg/25 mg		2010-09-14
	Extended-release Capsules	325 mg		2006-11-07
	Oral Suspension	750 mg/5 mL		2009-10-20
	Extended-release Tablets	4 mg		2008-10-31
	Capsules	200 mg/30 mg		2004-12-27
	Extended-release Tablets	3 mg		2009-01-08
	Tablets	150 mg		2007-10-30
	Extended-release Tablets	2 mg		2008-10-14
	Gum	4 mg		2013-01-22
	Extended-release Tablets	3 mg		2009-01-08
	Injection	6 mg/0.5 mL, 0.5 mL (prefilled syringes)		2006-05-09
	Tablets	0.25 mg, 0.5 mg, 1 mg and 2 mg		2004-12-22
	Tablets	250 mg/100 mg		2009-04-03
	Capsules	60 mg		2010-09-08
	Extended-release Capsules	225 mg and 425 mg		2006-10-11
	Extended-release Tablets	25 mg, 50 mg, 100 mg, 200 mg, 250 mg, and 300 mg		2014-02-12
	Extended-release Tablets	8 mg		2008-11-03
	Capsules	200 mg/38 mg		2016-02-16
	Extended-release Tablets	12 mg		2009-02-05

International Patents for GLAXOSMITHKLINE Drugs

Country	Patent Number	Estimated Expiration
United Kingdom	0217798
South Africa	200405722
Russian Federation	2010149050

Supplementary Protection Certificates for GLAXOSMITHKLINE Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0428642	57/2007	Austria		PRODUCT NAME: DOCOSANOL; NAT. REGISTRATION NO/DATE: 1-27014 20070518; FIRST REGISTRATION: SE 18517 20031114
1740177	PA2014038,C1740177	Lithuania		PRODUCT NAME: UMEKLIDINO BROMIDAS; REGISTRATION NO/DATE: EU/1/14/922 20140428
2316456	65/2017	Austria		PRODUCT NAME: NALTREXON ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE NALTREXONHYDROCHLORID, UND BUPROPION ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE BUPROPIONHYDROCHLORID; REGISTRATION NO/DATE: EU/1/14/988 (MITTEILUNG) 20150330

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Glaxo Grp England
• Glaxo Grp Ltd
• Glaxosmithkline